ABOUT THIS STUDY
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- Patients must be men or non-pregnant women (a documented negative pregnancy test at enrollment for females of child bearing age) at least 18 years of age
- Patients who present with a severe erosive esophagitis - confirmed by endoscopy (a baseline endoscopy within 24 hours of study enrollment) to be grade five or six, with or without stricture and/or ulcer
- Patients or their legally authorized representatives must be capable of understanding or giving signed and dated informed consent before the study
- Patients with a high probability for compliance and completion of the study
- Patients with less than grade five esophagitis
- Patients with esophagitis other than reflux esophagitis, such as infectious
esophagitis and esophageal cancer
- Patients who present with gastrointestinal bleeding, hematocrit decrease greater than
6 units or require more than 2 units transfusion at the presentation or during the
time of the study
- Patients with severe comorbidities, such as liver diseases with asparate transaminase
(AST) or alanine transaminase (ALT) greater than 3 times upper limit normal (ULN);
alkaline phosphatase greater than 5 times the ULN; total bilirubin greater than 3.0
mg/dl; kidney diseases with serum creatinine greater than 2.0 mg/dl in men or 1.6
mg/dl in women; heart diseases; lung diseases; sepsis; and airway intubation.
- Patients with history of glaucoma in either eye; history of any intraocular eye
surgery within preceding 3 months; history of, or presence of, signs of optic nerve
swelling; history of acute change in vision; or vision loss in either eye.
- Patients with any malignancy (except skin cancer) which required therapy within the
last 6 months
- Patients with history of allergy to any proton-pump inhibitor (PPI) including
pantoprazole
- Patients with known human immunodeficiency virus infection
- Patients with organ transplantation
- Patients without the ability to comply with the study protocol and complete the study
in the judgment of the investigator
- Patients with prior administration of any PPI (within 72 hours) or histamine-2
receptor antagonist (within previous 24 hours) of study enrollment
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Descriptive Information | ||||
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Brief Title ICMJE | Intravenous (IV) Pantoprazole in Erosive Esophagitis | |||
Official Title ICMJE | A Pilot Study of Efficacy and Safety of Continuous Intravenous Infusion of Pantoprazole in the Treatment of Severe Erosive Esophagitis | |||
Brief Summary | The aim of this study is to examine whether pantoprazole (Protonix) given through continuous intravenous infusion for 72 hours is superior to Protonix given through once a day IV injection in the treatment of erosive esophagitis. | |||
Detailed Description | Gastroesophageal reflux disease (GERD) is a very common disease that affects 20-50% of adults in Western Countries. The disease can be divided into three clinical categories: nonerosive reflux disease (NERD), erosive reflux disease (ERD), and Barrett's esophagus. Intravenous (IV) infusion produces a faster and steadier acid suppression than an oral regimen. Furthermore, some patients with severe erosive esophagitis cannot take pills by mouth and will benefit from an IV formulation. Recently, we observed healing of severe erosive esophagitis with continuous IV pantoprazole in several patients in 3 days. The safety of IV pantoprazole has been demonstrated in patients with GERD, with Zollinger-Ellison syndrome, or bleeding ulcer. This study is to define the safety and efficacy of continuous IV pantoprazole in the treatment of severe erosive esophagitis. Comparison: The continuous IV pantoprazole compared to the once a day IV pantoprazole for 72 hours in the treatment of severe erosive esophagitis. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Esophagitis | |||
Intervention ICMJE | Drug: pantoprazole
The continuous IV pantoprazole compared to the once a day IV pantoprazole for 72 hours in the treatment of severe erosive esophagitis Other Name: Protonix | |||
Study Arms ICMJE | Experimental: IV pantoprazole
The continuous IV pantoprazole compared to the once a day IV pantoprazole for 72 hours in the treatment of severe erosive esophagitis Intervention: Drug: pantoprazole | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 20 | |||
Original Enrollment ICMJE | 18 | |||
Actual Study Completion Date ICMJE | March 2007 | |||
Actual Primary Completion Date | July 2006 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00133770 | |||
Other Study ID Numbers ICMJE | 259-2004 3001K-200042 ( Other Grant/Funding Number: Wyeth ) | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Dr. Qiang Cai MD/PhD, Emory University | |||
Study Sponsor ICMJE | Emory University | |||
Collaborators ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Investigators ICMJE |
| |||
PRS Account | Emory University | |||
Verification Date | July 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |